Duns Number:151810868
Device Description: TRUEplus Pen Needles 32G x 5/32"
Catalog Number
S5H01A32-050
Brand Name
TRUEplus
Version/Model Number
TRUEplus Sterile Pen Needles
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
June 04, 2020
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
Yes
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K143437,K143437,K143437
Product Code
FMI
Product Code Name
Needle, Hypodermic, Single Lumen
Public Device Record Key
8f4cef48-5acf-457d-a5ec-9d12bfdd51f3
Public Version Date
July 19, 2021
Public Version Number
4
DI Record Publish Date
July 22, 2017
Package DI Number
10021292010314
Quantity per Package
45
Contains DI Package
00021292010317
Package Discontinue Date
June 04, 2020
Package Status
Not in Commercial Distribution
Package Type
CASE
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 25 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 22 |